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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device container, frozen donor tissue storage
Product CodeLPZ
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
CHARTER MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
ORIGEN BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fracture 22
Leak 15
Break 10
Device Issue 9
Material integrity issue 7
Fluid leak 7
Crack 5
Use of Device Issue 2
Misconnection 2
Torn material 2
Device handling issue 2
Defective item 1
Device markings issue 1
Device misassembled during manufacturing or shipping 1
Manufacturing or shipping issue associated with device 1
Material deformation 1
Material Distortion 1
Material puncture 1
Stretched 1
Material perforation 1
Incomplete or missing packaging 1
Disconnection 1
Total Device Problems 94

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